The FDA has revealed that another lot of metformin, a drug commonly used by type-2 diabetics, have been recalled over the presence of an impurity that is linked to the development of cancer. The recall announcement follows similar recent recalls from multiple companies after the FDA published the results of testing on metformin samples.
In late May, the FDA published an advisory warning that it had detected the presence of an impurity called NDMA in several lots of metformin extended-release. The agency said that it was seeking the recall of these batches from a total of five different companies, but that patients should continue to take the medication until a replacement was available.
In a new update on June 11, the FDA said that Lupin Pharmaceuticals has voluntarily recalled a single lot of its metformin hydrochloride extended-release tablets in 500mg strength over the detection of this impurity. N-Nitrosodimethylamine, more commonly called NDMA, is a contaminant found in many foods and water, among other things; though generally safe at low enough levels, it may be a cancer risk in excessive quantities.
The extended-release metformin recalled by Lupin is prescribed to help type-2 diabetes patients control their blood sugar levels. This lot features the 500mg strength drug sold in bottles of 60 tablets — they can be identified from the NDC number 6810-336-07. According to the FDA, they also feature lot number G901203 and an expiration date of December 2020.
This particular medication was distributed across the US through mail-order pharmacies, distributors, and wholesalers, the FDA says, all of which will be notified about the recall by Lupin. Patients should continue to take their medication until they get an alternative due to the greater risk of uncontrolled blood sugar compared to the impurity.